Trials / Active Not Recruiting

Active Not RecruitingNCT02465060

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Molecular Analysis for Therapy Choice (MATCH)

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 6,452 (estimated)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms. IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens. OUTLINE: STEP 0 (Screening): Patients undergo biopsy along with molecular characterization of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo collection of blood samples for research purposes. STEPS 1, 3, 5, 7 (Treatment): Patients are assigned to 1 of 38 treatment subprotocols based on molecularly-defined subgroup. (See Arms Section) STEPS 2, 4, 6 (Screening): Patients experiencing disease progression on the prior Step treatment or who could not tolerate the assigned treatment undergo review of their previous biopsy results to determine if another treatment is available or undergo another biopsy. Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy. STEP 8 (Optional Research): Consenting patients undergo end-of-treatment biopsy and collection of blood samples for research purposes. Additionally, patients may undergo a computed tomography (CT) scan, magnetic resonance imaging, and/or radionuclide imaging throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

Conditions

Interventions

Type	Name	Description
DRUG	Adavosertib	Given PO
DRUG	Afatinib	Given PO
DRUG	Afatinib Dimaleate	Given PO
DRUG	Binimetinib	Given PO
PROCEDURE	Biopsy Procedure	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Capivasertib	Given PO
PROCEDURE	Computed Tomography	Undergo computed tomography (CT)
DRUG	Copanlisib	Given IV
DRUG	Copanlisib Hydrochloride	Given IV
DRUG	Crizotinib	Given PO
OTHER	Cytology Specimen Collection Procedure	Optional correlative studies
DRUG	Dabrafenib	Given PO
DRUG	Dabrafenib Mesylate	Given PO
DRUG	Dasatinib	Given PO
DRUG	Defactinib	Given PO
DRUG	Defactinib Hydrochloride	Given PO
PROCEDURE	Echocardiography Test	Undergo echocardiography (ECHO)
DRUG	Erdafitinib	Given PO
DRUG	Fexagratinib	Given PO
DRUG	Ipatasertib	Given PO
OTHER	Laboratory Biomarker Analysis	Undergo molecular analysis
DRUG	Larotrectinib	Given PO
DRUG	Larotrectinib Sulfate	Given PO
PROCEDURE	Magnetic Resonance Imaging	Undergo magnetic resonance imaging (MRI)
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
BIOLOGICAL	Nivolumab	Given IV
DRUG	Osimertinib	Given PO
DRUG	Palbociclib	Given PO
BIOLOGICAL	Pertuzumab	Given IV
DRUG	PI3K-beta Inhibitor GSK2636771	Given PO
PROCEDURE	Radiologic Examination	Undergo radiologic evaluation
PROCEDURE	Radionuclide Imaging	Undergo nuclear study
BIOLOGICAL	Relatlimab	Given IV
DRUG	Sapanisertib	Given PO
DRUG	Sunitinib Malate	Given PO
DRUG	Taselisib	Given PO
DRUG	Trametinib	Given PO
BIOLOGICAL	Trastuzumab	Given IV
BIOLOGICAL	Trastuzumab Emtansine	Given IV
DRUG	Ulixertinib	Give PO
DRUG	Vismodegib	Given PO

Timeline

Start date: 2015-08-17
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2015-06-08
Last updated: 2026-04-13

Locations

1,414 sites across 3 countries: United States, Guam, Puerto Rico

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02465060. Inclusion in this directory is not an endorsement.